BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3170401 · Received June 7, 2013

    Report

    Report Number
    3004464228-2013-00582
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED DAMAGED LCD OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION WITH HYPOGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE ADVISES, "DO NOT USE THE PDM IF IT APPEARS DAMAGED OR IS NOT WORKING AS IT SHOULD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED RECENTLY WITH HYPOGLYCEMIA. SHE SAID THAT SHE MAY HAVE OVER-BOLUSED, AS THE BOTTOM PART OF HER PDM SCREEN IS BLACKENED OUT. SHE SAID THAT SHE IS UNABLE TO VIEW MOST OF THE SCREEN AND RELIES ON HER MEMORY. SHE SAID THAT SHE WAS UNABLE TO PROVIDE ANY HISTORY OF BOLUSES, BLOOD GLUCOSE RESULTS OR BASAL HISTORY BECAUSE OF THE SCREEN. SHE WANTED TO GET A NEW PDM, AS SHE SAID IT WAS VERY DIFFICULT FOR HER TO NAVIGATE THE SCREEN DURING HER RECENT HYPOGLYCEMIC EPISODE. SHE SAID THAT SHE CHECKED HERSELF INTO THE HOSPITAL, AND THE POD WAS REMOVED AND DISPOSED OF IN A BIOHAZARD BOX, SO SHE COULD NOT RETRIEVE IT. THE CUSTOMER DID NOT BELIEVE THAT THE POD CAUSED HER HYPOGLYCEMIA. SHE DECLINED TO PROVIDE FURTHER INFO REGARDING THE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253587 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L11976

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization